Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT07303192
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of i-PRF and LLLT on Free Gingival Graft Shrinkage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043309', 'term': 'proliferation regulatory factors, human urine'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft Area Shrinkage (%)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months postoperatively.', 'description': 'Change in graft surface area, expressed as percentage shrinkage from baseline. Standardized clinical photographs taken at baseline and at postoperative 1, 3, and 6 months were analyzed using calibrated digital image analysis software (ImageJ). The graft borders were traced, and surface area (mm²) was calculated. Each measurement was repeated three times, and the mean value was used. Shrinkage percentage was calculated using the formula:\n\nShrinkage % = \\[(baseline area - follow-up area) / baseline area\\] × 100.'}, {'measure': 'Root Coverage Percentage (%)', 'timeFrame': 'Baseline and 6 months postoperatively.', 'description': 'Percentage of root coverage obtained at 6 months. Root coverage was calculated from changes in gingival recession depth (RD) using the formula:\n\nRoot Coverage % = \\[(baseline RD - RD at 6 months) / baseline RD\\] × 100. RD was defined as the distance from the CEJ to the gingival margin and measured using a manual periodontal probe.'}, {'measure': 'Gingival Recession Depth (RD)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months postoperatively.', 'description': 'Change in gingival recession depth measured in millimeters.'}, {'measure': 'Keratinized Tissue Height (KTH)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months postoperatively.', 'description': 'Change in keratinized tissue height measured in millimeters.'}], 'secondaryOutcomes': [{'measure': 'Probing Depth (PD)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months postoperatively.', 'description': 'Change in probing depth measured in millimeters.'}, {'measure': 'Clinical Attachment Level (CAL)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months postoperatively.', 'description': 'Change in clinical attachment level measured in millimeters.'}, {'measure': 'Oedema Score in the Recipient Site', 'timeFrame': 'Postoperative days 3, 5, 7, 14, 21, and 28.', 'description': 'Oedema was scored clinically in the recipient area using a 0-4 ordinal scale (0 = none; 1 = mild, intraoral oedema limited to the surgical site; 2 = moderate, extraoral oedema limited to the surgical site; 3 = significant, extraoral oedema extending beyond the surgical site; 4 = severe, extraoral oedema extending beyond the surgical site with limited mouth opening). Examinations were performed by a calibrated and blinded examiner. Higher scores indicate more severe oedema.\n\nUnit of Measure: Units on a scale (0-4)'}, {'measure': 'Erythema Score in the Recipient Site', 'timeFrame': 'Postoperative days 3, 5, 7, 14, 21, and 28.', 'description': 'Erythema was scored clinically in the recipient area using a 0-4 ordinal scale (0 = none, tissues fully pink; 1 = mild, \\<25% of tissues red; 2 = moderate, 25-50% of tissues red; 3 = significant, 50-75% of tissues red; 4 = severe, \\>75% of tissues red). Examinations were performed by a calibrated and blinded examiner. Higher scores indicate greater severity of erythema.'}, {'measure': 'Pain Intensity (VAS Score)', 'timeFrame': 'First postoperative week.', 'description': 'Postoperative pain intensity was assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = maximum tolerable pain. Patients recorded their pain level daily during the first postoperative week. Higher scores indicate greater pain intensity.'}, {'measure': 'Analgesic Consumption', 'timeFrame': 'First postoperative week.', 'description': 'The number of analgesic tablets taken during the first postoperative week was recorded by each patient on a provided daily log form. Higher values indicate greater postoperative analgesic use.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['free gingival graft', 'shrinkage', 'low-level laser therapy', 'injectable platelet-rich fibrin'], 'conditions': ['Graft Shrinkage', 'Gingival Recession, Localized']}, 'referencesModule': {'references': [{'pmid': '39984903', 'type': 'BACKGROUND', 'citation': 'Shakiliyeva S, Sahin D, Gunpinar S, Gursel M. Comparison of conventional and modified sling suture techniques in free gingival graft operations-a randomized controlled clinical trial. BMC Oral Health. 2025 Feb 21;25(1):279. doi: 10.1186/s12903-025-05456-x.'}], 'seeAlsoLinks': [{'url': 'https://www.inonu.edu.tr/klinik.etik', 'label': 'Inonu University Clinical Research Ethics Committee'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to evaluate whether injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) can reduce graft shrinkage after free gingival graft procedures. Free gingival grafts are commonly used to increase the width of keratinized tissue around teeth, but the graft often shrinks during healing. In this study, patients will receive standard free gingival graft surgery with or without additional i-PRF or laser therapy. The goal is to determine whether these treatments improve healing and help maintain the size of the graft.', 'detailedDescription': 'This randomized controlled clinical trial investigates the effects of injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) on the shrinkage of free gingival grafts (FGG) used to treat gingival recession. Free gingival grafting is commonly performed to increase the width of keratinized tissue around teeth, but shrinkage during healing can reduce clinical outcomes.\n\nThe study included 48 systemically healthy adult patients with Cairo Class I gingival recession in mandibular anterior teeth. Participants were randomly assigned to one of three groups: control (FGG alone), i-PRF (FGG + platelet-rich fibrin), or LLLT (FGG + low-level laser therapy). Ethical approval was obtained from the Clinical Research Ethics Committee of Inonu University (Protocol No: 2024/84), and all participants provided written informed consent. The study protocol was registered at ClinicalTrials.gov (NCT06744270) and conducted according to CONSORT 2010 guidelines.\n\nAll patients received preoperative periodontal treatment, including plaque removal and oral hygiene instructions. Free gingival grafts were harvested from the palatal region and adapted to the recipient site, then stabilized with sutures. In the i-PRF group, autologous platelet-rich fibrin gel was applied to the graft surface. In the LLLT group, laser therapy was applied immediately after surgery and on postoperative days 3, 5, 7, and 14. The control group received no additional treatment beyond standard grafting.\n\nPostoperative care included use of a periodontal dressing, chlorhexidine mouthwash, analgesics as needed, and oral hygiene instructions after suture removal. Clinical evaluations included gingival recession depth, keratinized tissue height, probing depth, clinical attachment level, and graft area measurements at baseline, 1, 3, and 6 months. Edema, erythema, and patient-reported pain were also assessed during follow-up.\n\nThe primary outcome of the study was graft shrinkage, calculated as the percentage decrease in graft area over time. Secondary outcomes included clinical parameters and patient-reported postoperative morbidity. All measurements were performed by calibrated, blinded examiners to ensure reliability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years.\n* Systemically healthy.\n* Cairo Class I gingival recession in vital mandibular anterior incisors.\n* No caries or restorations in the relevant teeth.\n* Keratinized gingiva height \\< 2 mm in the included teeth.\n* Plaque Index (PI) \\< 1.\n* Gingival Index (GI) \\< 1.\n\nExclusion Criteria:\n\n* Active periodontal disease or probing depth \\> 3 mm.\n* Use of medications that could prevent surgery or affect wound healing.\n* Pregnancy or breastfeeding.\n* History of periodontal surgery in the working area.\n* Active smokers.\n* Current orthodontic treatment.'}, 'identificationModule': {'nctId': 'NCT07303192', 'briefTitle': 'Effect of i-PRF and LLLT on Free Gingival Graft Shrinkage', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'The Effect of Injectable Platelet-Rich Fibrin and Low-Level Laser Therapy on Graft Shrinkage in Free Gingival Grafts: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2024/84'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients receive free gingival graft only without additional treatment.', 'interventionNames': ['Procedure: Free Gingival Graft (FGG)']}, {'type': 'EXPERIMENTAL', 'label': 'i-PRF group', 'description': 'Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface.', 'interventionNames': ['Procedure: Free Gingival Graft (FGG)', 'Device: Low-Level Laser Therapy (LLLT)']}, {'type': 'EXPERIMENTAL', 'label': 'LLLT Group', 'description': 'Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14.', 'interventionNames': ['Procedure: Free Gingival Graft (FGG)', 'Biological: Injectable Platelet-Rich Fibrin (i-PRF)']}], 'interventions': [{'name': 'Free Gingival Graft (FGG)', 'type': 'PROCEDURE', 'description': 'Standard free gingival graft procedure performed without additional treatments.', 'armGroupLabels': ['Control Group', 'LLLT Group', 'i-PRF group']}, {'name': 'Injectable Platelet-Rich Fibrin (i-PRF)', 'type': 'BIOLOGICAL', 'description': 'Autologous platelet-rich fibrin gel is applied to the graft surface after free gingival graft surgery to potentially reduce graft shrinkage.', 'armGroupLabels': ['LLLT Group']}, {'name': 'Low-Level Laser Therapy (LLLT)', 'type': 'DEVICE', 'description': 'Low-level laser therapy is applied to the graft site immediately after surgery and on postoperative days 3, 5, 7, and 14 to potentially improve healing and reduce graft shrinkage.', 'armGroupLabels': ['i-PRF group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaraş Sütçü İmam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'overallOfficials': [{'name': 'esra bozkurt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kahramanmaras Sutcu Imam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared to ensure patient privacy and confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Esra Bozkurt', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}